other
Posted 16 hours agoProject Manager Patient Safety
at Fortrea
On-site
Responsibilities
- Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.
- Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
- Ensure case receives appropriate medical review.
- Prepare follow-up correspondence consulting with the medical staff accordingly.
- Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.
- Review the coding of adverse events.
- Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel, if required, within study specified timelines.
- Execute and/or ensure routine quality review of adverse event reports and aggregate reports ensuring that case processing and data quality meet global regulatory compliance standards for assigned projects.
- Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget.
- Prepare and participate in audits, either by the client or a regulatory agency.
- Manage the review of cumulative safety data for submission to DSMBs, regulatory authorities or clients.
- Manage the set-up of, and the provision of data to Safety Committees / Drug Safety Monitoring Boards.
- Manage the co-ordination of endpoint committees as needed.
- Prepare and deliver safety presentations: Serious Adverse Event reporting at investigator meetings.
- Build and maintain good drug safety relationships across functional units.
- Demonstrate role specific Competencies on consistent basis.
- Demonstrate company Values on a consistent basis.
- Provide leadership and management of global or regional projects ensuring that communications and processes are harmonized for assigned projects.
Requirements
- Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions and system functionality.
- Maintains a comprehensive understanding of PSS SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other CDS procedural documents, e.g., SOPs, WIs, etc. impacting safety.
- Qualifications (Minimum Required): Non-degree + 6-7 yrs. Safety experience
- Associate degree + 5-6 yrs. Safety experience
- Associate degree RN + 5-6 yrs. Safety experience
- BS/BA + 4-5 yrs. Safety experience
- For PharmD, a one-year residency of fellowship can be considered relevant experience.
- Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
- experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and
- experience with regulatory submissions. *
- experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
- Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.
- Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines.
- Good knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
- Good knowledge of ICH guidelines.
- Good knowledge of medical and drug terminology.
- Knowledge of aggregate reporting.
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
- Qualifications Include: EudraVigilance Certification preferred.
- Knowledge of Medical Device Reporting desirable.
Additional details
- Job Overview: Manage ‘Client’ or ‘Project’ specific PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports) for specified projects.
- The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.
- Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
- The role will be expected to comply with the legal
- requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary of
- Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
- Work closely with the clinical operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements.
- Provide oversight of the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial for assigned projects.
- This includes, but is not limited to: Entry of safety data onto adverse event database(s) and tracking systems.
- Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.